Apparatus for intravenous administration of a fluid from a dual-chamber flask having an internal upset-table septum normally separating two axially-in-line chambers and having a pierceable end stopper

ABSTRACT

A standard drip meter assembly of the type having an upstanding stopper piercer with both an air inlet and a passage for the fluid into the drip meter, is supplemented by a solid airinletting spike with a socket fitting over the stopper piercer and having a long shank that terminates in a non-coring piercing end. Passages adjacent the socket communicate with the air inlet and the passage in the drip meter stopper piercer. The supplemental spike is long enough to upset the septum after it pierces the stopper of a dual-chamber flask. An advantage is that inletting air then enters near the bottom of the flask to help agitate the fluid. An initiating pumping device for hand operation is provided adjacent the outlet of the drip meter.

ilnited States Patent Dabney 51 June 20, 1972 APPARATUS FOR INTRAVENOUS ADMINISTRATION OF A FLUID FROM A DUAL-CHAMBER FLASK HAVING AN INTERNAL UPSET-TABLE SEPTUM NORMALLY SEPARATING TWO AXIALLY-IN-LINE CHAMBERS AND HAVING A PIERCEABLE END STOPPER [72] Inventor: William C. Dabney, Oakland, Calif.

[73] Assignee: Cutter Llborltorles, Inc., Berkeley, Calif.

[22) Filed: June I, I970 [21] Appl. No.2 4|,866

3,292,624 l2/l966 Gabrieletal, 128/221 2,362.l03 ll/l944 Smith ..l28/272 FOREIGN PATENTS OR APPLICATIONS 1,225,859 2/l960 France ..l28/2l4C l96.566 3/l958 Austria ,.l28/2l4C ABSTRACT A standard drip meter assembly of the type having an upstanding stopper piercer with both an air inlet and a passage for the fluid into the drip meter, is supplemented by a solid air-inletting spike with a socket fitting over the stopper piercer and having a long shank that terminates in a non-coring piercing end. Passages adjacent the socket communicate with the air inlet and the passage in the drip meter stopper piercer. The supplemental spike is long enough to upset the septum after it pierces the stopper of a dual-chamber flask. An advantage is that inletting air then enters near the bottom of the flask to help agitate the fluid. An initiating pumping device for hand operation is provided adjacent the outlet of the drip meter.

7 Claims, 6 Drawing Figures PATENTEDJUMZO 1972 3,670,728

INVENTOR. WILLIAM C. DABNEY Y (awe/Maw ATTORNEYS APPARATUS FOR INTRAVENOUS ADMINISTRATION OF A FLUID FROM A DUAL-CHAMBER FLASK HAVING AN INTERNAL UPSET-TABLE SEPTUM NORMALLY SEPARATING TWO AXIALLY-IN-LINE CHAMBERS AND HAVING A PIERCEABLE END STOPPER BACKGROUND OF THE INVENTION Drip meters are available already with closure members on their upper end that are integrally provided with stopper piercers for entering stoppered holding intravenous solutions. Near their upper ends, the stopper piercers have a fluid outlet and an inlet for air to replace the fluid. In some instances, however, the intravenous solution embodies two materials that must not be mixed until very shortly before the time of administration. These materials, which may comprise two liquids to be mixed or a liquid and a solid to be dissolved in the liquid, can be sterilely packaged in a dual-chamber flask. Such a flask may have two axially-in-line chambers with a septum separating the two chambers, so that a liquid may be in one chamber and an other liquid or a solid in the second chamber. One end of the flask may be solid, and the other end may be provided with a pierceable stopper of a conventional kind. When the stopper is pierced and the septum is dislodged or upset, the two materials are then mixed, preferably with the aid of some initial shaking, to form a single solution.

A significant problem is how to provide a drip meter with a stopper piercing device that can be used with a dual-chamber flask in such a way that the same element which pierces the stopper can also upset the septum.

The obvious proposal is to replace the normal stopper piercer with a longer one just like it, having an air inlet and a fluid outlet at the upper end. This proposal, however, has several disadvantages, less obvious than the proposal itself. For one thing, the fluid outlet passage should have its inlet lower down, in order to continue to dispense the fluid as the supply in the flask is depleted. For another, the air inlet, if provided by a central passageway extending through the pointed end, causes the spike end to remove from the stopper a central core, and this is dangerous, for this free core may get into the patients bloodstream and block it somewhere, or it may block the flow of the intravenous solution into the patient.

Furthermore, the replacement of some stopper piercers with others results in two more expensive non-interchangeable lines of products. The long-stemmed stopper piercer for dualchamber flasks may be quite undesirable for short single chamber flasks. The doctor or hospital must carry a larger stock or risk being out of what is needed.

There are some other problems. One of these is to provide sufficient agitation during administration to render separation of the materials less likely and to provide additional mixing where the initial mixing of the two materials was hastily and incompletely carried out. Another, is to provide means for inducing an initial rapid air-purging flow of the liquid into and from the drip meter without having to later detach a pump therefrom and having then to attach the drip meter to the tubing leading to the patient.

SUMMARY OF THE INVENTION This invention utilizes a standard drip meter and provides a supplemental spike that fits over the standard short stopper piercer and has an elongated solid stem or shank that terminates in a solid point. Being solid, the spike is non-coring. At the bottom of the stem or shank, this supplemental spike has a socket that fits over the short stopper piercer of the drip meter and is provided with two through openings, one leading to the fluid passage of the drip meter and the other to the air inlet of the drip meter. As a result, the liquid inlet to the drip meter remains as low as in the standard drip meter stopper piercer, while a most interesting special advantage is simultaneously obtained,the air enters the flask at a low level and bubbles up through the liquid, helping to agitate it and thereby aid mixture if needed and to maintain homogeneity of the solution. Economy and a more adaptable stock becomes possible, since both single-solution flasks and dual-chamber flasks use the same drip meter, with the dual chamber flasks utilizing a simple attachment.

A pumping arrangement is provided by the connector between the outlet from the drip meter and the tubing leading to the patient.

Other objects and advantages of the invention will appear from the following description of a preferred embodiment.

BRIEF DESCRIPTION OF THE DRAWINGS In the drawings:

FIG. I is a view in elevation and partly in section of apparatus embodying the principles of the invention in use in connection with a dual chamber flask. The initial, closure position of the septum is shown in broken lines and its upset position shown in solid lines.

FIG. 2 is an enlarged view in elevation and in section of the supplemental spike of this invention.

FIG. 3 is a view in section taken along the line 3-3 in FIG. 2.

FIG. 4 is a top view looking down along the line 4-4 in FIG. 2.

FIG. 5 is a bottom view looking up along the line 5-5 in FIG. 2.

FIG. 6 is a fragmentary view in section of the bottom portion of the flask showing its pierceable stopper before it is pierced.

DESCRIPTION OF THE PREFERRED EMBODlMENT A dual chamber flask 10 is shown in FIG. 1. The flask 10 has an enlarged upper chamber 11 and a smaller diameter chamber 12 axially in line with the chamber 1 l. The flask 10 is closed by a pierceable stopper 13 having a thin central portion 14 (FIG. 6), and the two chambers l l and 12 are normally divided from each other by a septum 15 located at the end of the chamber 12 where the two chambers l l and 12 meet. The two chambers 11 and 12 may be identical in diameter, and other shapes of septums, chambers and so on may be used.

The purpose of the invention is to supply a sterile intravenous solution from the flask 10 to a patient with the aid of an apparatus which can first pierce the stopper 13 and thereafter can upset the septum 15 to enable mixing of the two materials in the flask 10, and then can feed it via a drip chamber to the patient.

The invention incorporates the use of a drip chamber unit 20 which is already on the market (cf. US. Pat. No. 3,092,106). The drip chamber unit 20 has a transparent main wall 21 which is preferably frustoconical and terminates at a lower end in an outlet fitting 22. The outlet fitting 22 receives a portion 23 of a rubber tube 24 which has a lower end 25 that connects to an outlet tube 26. In between the portions 23 and 25 the tube 24 has an enlarged pumping portion 27 which can be alternatingly squeezed and released with the fingers to induce quicker flow of the liquid into and from the drip chamber unit 20.

The upper end of the drip chamber unit 20 is provided with a closure member 30 having a cap portion 31, an angle portion 32, and an integral stopper piercer 33. The stopper piercer 33 has a generally cylindrical portion 34 extending upwardly and terminating in a generally conical pointed end 35. Parallel to the axis of the upwardly extending cylindrical portion 34 but displaced from it are two passageways 36 and 37, both of them opening along the generally conical part of the pointed end 35. The passageway 36 is vertical and serves to lead liquid down into a drip tube 38 at the upper end of a drip chamber 40, and it is from its end 41 that the dripping takes place. The passageway 37 provides inletting air; it extends vertically and then angles out through the angle portion 32 via a passageway 42 to an air inlet 43. The air inlet 43 is provided with a tubular cap 44 which also retains a filter 45 to filter the air and to keep it from from foreign matter.

In the present invention an auxiliary or supplementary spike 50 is provided. This auxiliary spike 50 (see FIGS. 2-5) has a base portion 51 with a shoulder 52 and an interior socket portion 53. Above the shoulder 52 is an inlet portion 54 succeeded by an elongated stem 55 that is smaller in diameter than the inlets portion 54. The stem or shank 55 is preferably generally cylindrical, though it may be another shape, and ends in a preferably conically pointed portion 56. The entire stem 55, as well as the pointed portion, is solid so that it is noncoring. The spike 50 can thus enter the stopper 13 at its thinnest central portion 14 without removing any core of material from the stopper 13. The length of the auxiliary spike 50 above the shoulder 52 is long enough to insure that it will not only go through the stopper 13 but will also extend far enough to engage the septum l5 and dislodge it to connect the two chambers 11 and 12 of the flask 10.

The auxiliary spike 50 at its inlets portion 54 below the stem 55 and above the shoulder 52 is provided with two through openings or slots 57 and 58, which connect respectively with the two passageways 37 and 36. The socket 53 is provided with a cylindrical bore 60 and a conical end portion 61 which mate exactly with the cylindrical portion 34 and the conical end 35 of the stopper piercer 33, and seat the stopper piercer 33 and seal it, with the openings 57 and 58 properly aligned. The auxiliary spike 50 may be made of flexible polyethylene, whereas the drip chamber unit 20 may be typically made of a more rigid clearly transparent plastic material.

All parts are sterilized before use. The drip chamber 20 can be used with a single-solution flask in the usual manner. When a dual-chamber flask is to be used, the supplemental spike 50 is installed on the drip chamber unit by pushing into place. Then the solid spike end 56 is used to pierce the stopper l3 and subsequently to upset the septum 15. The two materials, one in the chamber 11 and one in the chamber 12, are then mixed by shaking the flask. The parts are then placed into the vertical position shown in FIG. 1, and the solution from the flask flows into the inlet 58 and thence into the passageway 36 to the drip tube 38, from which the solution drips into the drip chamber 40. The normally slow drip is accelerated by pumping the member 27 for a while to obtain a desired level in the drip chamber 40 and to clear the tube 26 of air.

In the meantime, air enters through the inlet 43 and flows through the filter 45, the passageways 42 and 37 and the inlet 57 into the flask 10. There it bubbles up through the liquid and above it, enabling the flow of the liquid which it displaces. Its bubbling agitates the solution and assures a good mixture thereof.

To those skilled in the art to which this invention relates, many changes in construction and widely differing embodiments and applications of the invention will suggest themselves without departing from the spirit and scope of the inventionv The disclosures and the description herein are purely illustrative and are not intended to be in any sense limiting.

1 claim:

1. Apparatus for intravenous administration of a fluid, including in combination:

a dual chamber flask having an internal upsettable septum normally separating two axially-in-line chambers and having a pierceable stopper at one end spaced from said septum,

a drip meter assembly having a vessel with a tube adapter on a lower end thereof and a closure member on an upper end, said closure member having an upstanding shank with a pointed upper end and two passages therethrough, each having an opening adjacent said upper end axially displaced from and on opposite sides of the centerline of said shank, a first said passage communicating with a filtered air inlet at one side of said closure member, a second said passage continuing down through a tube portion depending from said closure member into the upper end of the transparent vessel and having a drip outlet, and

an air inletting auxiliary spike having an elongated solid stem with a solid non-coring point at one end, an inlets portion at the other end, and a base portion therebelow having an interior socket fitting over said shank, said inlets portion having two through openings, each communicating directly with one of said two passages,

the length of said spike above said shoulder being longer than the distance between said stopper and said septum, so that said spike can enter said stopper and upset said septum,

said fluid then flowing through said inlets portion and said second passage into said drip meter, while air flows in through said filtered inlet and said first passage into said flask closely adjacent the pierced stopper, so that inletted air bubbles up through the solution in said stopper and agitates it.

2. The apparatus of claim 1 having a rubber connector fitting around said tube adapter and around a succeeding tube, said connector having an enlarged central pumping portion between its end portions.

3. Apparatus for intravenous administration of a fluid, including in combination:

a dual chamber flask having an internal upsettable septum normally separating two axially-in-line chambers and having a pierceable stopper at one end spaced from said septurn,

a drip meter assembly having a transparent vessel with a tube adapter on a lower end thereof and a closure member on an upper end,

said closure member having an upstanding generally cylindrical shank with a conical pointed upper end and two passages therethrough, each having an opening adjacent said upper end axially displaced from and on opposite sides of the centerline of said shank and therefore opening on opposite sides of the point, a first said passage communicating with a filtered air inlet at one side of said closure member, the second said passage communicating with a tube portion depending from said closure member and axial of said vessel and having a drip outlet, and

an air inletting auxiliary spike having a generally cylindrical elongated solid stem with a solid non-coring point at one end, an enlarged lower inlets portion therebelow, and a shouldered base portion below that having an interior axial bore with a pointed conical upper end fitting over said generally cylindrical shank, seating its point and in sealing relation with its exterior surface, said inlets portion having two through openings, each communicating directly with one of said two passages,

the length of said spike above said shoulder being longer than the distance between said stopper and said septum, so that said spike can enter said stopper and upset said septum,

said fluid then flowing through said inlets portion and said second passage into said drip meter, while air flows in through said filtered inlet and said first passage into said flask at a level closely adjacent the pierced stopper.

4. A one-piece supplemental spike for use with a dual chamber flask having an internal upsettable septum normally separating two axially-in-line chambers and having a pierceable stopper at one end spaced from said septum, for adapting thereto a drip meter assembly having a transparent vessel with a tube adapter on a lower end thereof and a closure member on an upper end having an upstanding shank with a pointed upper end, said shank being too short to engage said septum if it were to pierce said stopper, said shank having two passages therethrough, each having an opening adjacent said upper end axially displaced from and on opposite sides of the centerline of said shank, a first said passage for inlet air and a second said passage for conducting liquid into the vessel, said spike comprising:

an elongated solid stem with a solid non-coring point at one end, and integral with said stem, an inlets portion at the other end, and a shouldered base portion therebelow forming the end of said spike and having an interior socket for fitting over said shank, said socket terminating just above said base portion said inlets portion having two through openings opposite each other, each adapted to communicate directly with one of said two passages,

the length of said spike above said shoulder being longer than the distance between said stopper and said septum, so that said spike can enter said stopper and upset said septum.

5. The spike of claim 4 wherein said shank, bore, and stem are cylindrical.

6. A one-piece air inletting spike for addition to the stopper piercer of a drip meter assembly to adapt to a dual chamber flask, comprising:

an elongated solid stem with an integral solid non-coring point at one end and an enlarged inlets portion at the other end just above a shouldered base portion forming the end of said spike,

socket means at the lower end of said spike for fitting over said stopper piercer, seating its point and in sealing relation with its exterior surface,

said inlets portion having two directly opposite through openings, one for air inlet and one for liquid outlet, for communicating with said stopper piercer,

the length of said spike above said shoulder being longer than the distance between said stopper and said septum, so that said spike can enter said stopper and upset said septum.

7. A one-piece air inletting spike comprising:

an elongated solid cylindrical stem with a solid non-coring point at one end and an enlarged inlets portion at the other end, said inlets portion having two directly opposite through openings, one for air inlet and one for liquid outlet, and

socket means at said other end of said spike terminating at said inlets portion,

said solid cylindrical stem constituting more than half of the length of said spike. 

1. Apparatus for intravenous administration of a fluid, including in combination: a dual chamber flask having an internal upsettable septum normally separating two axially-in-line chambers and having a pierceable stopper at one end spaced from said septum, a drip meter assembly having a vessel with a tube adapter on a lower end thereof and a closure member on an upper end, said closure member having an upstanding shank with a pointed upper end and two passages therethrough, each having an opening adjacent said upper end axially displaced from and on opposite sides of the centerline of said shank, a first said passage communicating with a filtered air inlet at one side of said closure member, a second said passage continuing down through a tube portion depending from said closure member into the upper end of the transparent vessel and having a drip outlet, and an air inletting auxiliary spike having an elongated solid stem with a solid non-coring point at one end, an inlets portion at the other end, and a base portion therebelow having an interior socket fitting over said shank, said inlets portion having two through openings, each communicating directly with one of said two passages, the length of said spike above said shoulder being longer than the distance between said stopper and said septum, so that said spike can enter said stopper and upset said septum, said fluid then flowing through said inlets portion and said second passage into said drip meter, while air flows in through said filtered inlet and said first passage into said flask closely adjacent the pierced stopper, so that inletted air bubbles up through the solution in said stopper and agitates it.
 2. The apparatus of claim 1 having a rubber connector fitting around said tube adapter and around a succeeding tube, said connector having an enlarged central pumping portion between its end portions.
 3. Apparatus for intravenous administration of a fluid, including in combination: a dual chamber flask having an internal upsettable septum normally separating two axially-in-line chambers and having a pierceable stopper at one end spaced from said septum, a drip meter assembly having a transparent vessel with a tube adapter on a lower end thereof and a closure member on an upper end, said closure member having an upstanding generally cylindrical shank with a conical pointed upper end and two passages therethrough, each having an opening adjacent said upper end axially displaced from and on opposite sides of the centerline of said shank and therefore opening on opposite sides of the point, a first said passage communicating with a filtered air inlet at one side of said closure member, the second said passage communicating with a tube portion depending from said closure member and axial of said vessel and having a drip outlet, and an air inletting auxiliary spike having a generally cylindrical elongated solid stem with a solid non-coring point at one end, an enlarged lower inlets portion therebelow, and a shouldered base portion below that having an interior axial bore with a pointed conical upper end fitting over said generally cylindrical shank, seating its point and in sealing relation with its exterior surface, said inlets portion having two through openings, each communicating directly with one of said two passages, the length of said spike above said shoulder being longer than the distance between said stopper and said septum, so that said spike can enter said stopper and upset said septum, said fluid then flowing through said inlets portion and said second passage into said drip meter, while air flows in through said filtered Inlet and said first passage into said flask at a level closely adjacent the pierced stopper.
 4. A one-piece supplemental spike for use with a dual chamber flask having an internal upsettable septum normally separating two axially-in-line chambers and having a pierceable stopper at one end spaced from said septum, for adapting thereto a drip meter assembly having a transparent vessel with a tube adapter on a lower end thereof and a closure member on an upper end having an upstanding shank with a pointed upper end, said shank being too short to engage said septum if it were to pierce said stopper, said shank having two passages therethrough, each having an opening adjacent said upper end axially displaced from and on opposite sides of the centerline of said shank, a first said passage for inlet air and a second said passage for conducting liquid into the vessel, said spike comprising: an elongated solid stem with a solid non-coring point at one end, and integral with said stem, an inlets portion at the other end, and a shouldered base portion therebelow forming the end of said spike and having an interior socket for fitting over said shank, said socket terminating just above said base portion said inlets portion having two through openings opposite each other, each adapted to communicate directly with one of said two passages, the length of said spike above said shoulder being longer than the distance between said stopper and said septum, so that said spike can enter said stopper and upset said septum.
 5. The spike of claim 4 wherein said shank, bore, and stem are cylindrical.
 6. A one-piece air inletting spike for addition to the stopper piercer of a drip meter assembly to adapt to a dual chamber flask, comprising: an elongated solid stem with an integral solid non-coring point at one end and an enlarged inlets portion at the other end just above a shouldered base portion forming the end of said spike, socket means at the lower end of said spike for fitting over said stopper piercer, seating its point and in sealing relation with its exterior surface, said inlets portion having two directly opposite through openings, one for air inlet and one for liquid outlet, for communicating with said stopper piercer, the length of said spike above said shoulder being longer than the distance between said stopper and said septum, so that said spike can enter said stopper and upset said septum.
 7. A one-piece air inletting spike comprising: an elongated solid cylindrical stem with a solid non-coring point at one end and an enlarged inlets portion at the other end, said inlets portion having two directly opposite through openings, one for air inlet and one for liquid outlet, and socket means at said other end of said spike terminating at said inlets portion, said solid cylindrical stem constituting more than half of the length of said spike. 